Impact of the Sustained Viral Response of Chronic Hepatitis c After Treatment With Direct Action Antivirals

Hepatitis C, Chronic Clinical Trial

— Hepatitis  

Official title:

Impact of the Sustained Viral Response on the Natural History Chronic Hepatitis c After Treatment With Direct Action Antivirals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05062408
• Other study ID #: FIS-ANT- 2021-01
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: January 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved SVR after treatment with direct-acting antivirals.

Description:

This open study includes patients with chronic hepatitis C who received treatment with the new direct-acting antivirals between November 1, 2014 and December 31, 2017, who achieved a sustained viral response at week 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with chronic liver disease caused by virus C.
• Have received treatment with the new DAAs between November 1, 2014 and December 1, 2017.
• Patients diagnosed with advanced fibrosis and liver cirrhosis. Advanced fibrosis was defined as a Fibroscan> 10 kPa, an APRI index> 1.5 and / or a FIB-4 index> 3.25. For its part, cirrhosis was defined such as a Fibroscan> 12.5 kPa and / or presence of esophagogastric varices in the endoscopic study and / or data portal hypertension ultrasound.

Exclusion Criteria:

• Coinfection by virus B or HIV.
• Development of HCC before or during treatment.
• Abuse of alcohol intake or addiction to parenteral drugs.
• Liver disease of non-viral etiology (autoimmune, toxic, metabolic).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a progression of liver injury.	To assess the evolution of liver injury with fibrosis data in patients who achieved SVR after treatment with direct-acting antivirals.	Up to 4 weeks
Secondary	Identify patients who develop liver-related events (liver decompensation, hepatocellular carcinoma, and death) after achieving sustained viral response.	Development of hepatic decompensation, defined as a patient with ascites, spontaneous bacterial peritonitis (PBR), digestive bleeding of varicose origin, or hepatic encephalopathy at some point in the evolution from SVR until the end of study follow-up.	Up to 4 weeks.
Secondary	Rate of risk factors presented by patients.	Identify risk factors in patients who develop liver complications after achieving sustained viral response.	Up to 4 weeks.
Secondary	Absence of improvement in non-invasive fibrosis parameters vs the development of liver complications.	To determine if there is a relationship between the absence of improvement in non-invasive fibrosis parameters and the development of liver complications.	Up to 4 weeks.
Secondary	Clinical and fibrosis data.	To compare the clinical and fibrosis data between patients who develop liver complications and those who do not.	Up to 4 weeks.